Product description
Product name: EMEND TRI-PACK
Company name:
MERCK CANADA INC
DIN: 02298813
Status: Marketed
Status date: 2007-09-24
Active ingredient(s) |
Strength |
APREPITANT |
125 MG
|
APREPITANT |
80 MG
|
Resources
Click on a resource to visit a page with more information. You may be taken away from this page to a different Government of Canada website.
For consumers
Resource |
Description |
Report a side effect |
Side effects are troublesome symptoms or feelings that you may not expect that show up when you are taking a medicine.
All suspected side effects should be reported, especially those that are:
- Unexpected, regardless of their severity, i.e., not consistent with product information or labelling; or
- Serious, whether expected or not, i.e., that requires being admitted to the hospital, lengthened hospital stay, causes a birth defect, disability, is life-threatening or results in death;
- Reactions to recently marketed health products (on the market for less than five years), regardless of their nature or severity.
|
For health care professionals
Resource |
Description |
Summary Basis of Decision for Emend ™
|
The Summary Basis of Decision explains why the product was approved for sale in Canada. The document includes regulatory, safety, effectiveness and quality (in terms of chemistry and manufacturing) considerations.
|
Report a serious adverse drug reaction (for hospitals) |
Section C.01.020.1 of the Food and Drug Regulations and section 62 of the Medical Devices Regulations, require hospitals to report to Health Canada all serious adverse drug reactions (ADRs) and medical device incidents (MDIs) within 30 days of being documented within the hospital.
This regulatory requirement only applies to hospitals.
|
For researchers
Resource |
Description |
Summary Basis of Decision for Emend ™
|
The Summary Basis of Decision explains why the product was approved for sale in Canada. The document includes regulatory, safety, effectiveness and quality (in terms of chemistry and manufacturing) considerations.
|
Search Clinical Information |
After Health Canada completes the regulatory review process for a product, the clinical information included in a submission is made publicly available for non-commercial purposes. |
All resources
Resource |
Description |
Summary Basis of Decision for Emend ™
|
The Summary Basis of Decision explains why the product was approved for sale in Canada. The document includes regulatory, safety, effectiveness and quality (in terms of chemistry and manufacturing) considerations.
|
Search Clinical Information |
After Health Canada completes the regulatory review process for a product, the clinical information included in a submission is made publicly available for non-commercial purposes. |
Report a side effect |
Side effects are troublesome symptoms or feelings that you may not expect that show up when you are taking a medicine.
All suspected side effects should be reported, especially those that are:
- Unexpected, regardless of their severity, i.e., not consistent with product information or labelling; or
- Serious, whether expected or not, i.e., that requires being admitted to the hospital, lengthened hospital stay, causes a birth defect, disability, is life-threatening or results in death;
- Reactions to recently marketed health products (on the market for less than five years), regardless of their nature or severity.
|
Report a serious adverse drug reaction (for hospitals) |
Section C.01.020.1 of the Food and Drug Regulations and section 62 of the Medical Devices Regulations, require hospitals to report to Health Canada all serious adverse drug reactions (ADRs) and medical device incidents (MDIs) within 30 days of being documented within the hospital.
This regulatory requirement only applies to hospitals.
|
Resource |
Description |
Report a side effect |
Side effects are troublesome symptoms or feelings that you may not expect that show up when you are taking a medicine.
All suspected side effects should be reported, especially those that are:
- Unexpected, regardless of their severity, i.e., not consistent with product information or labelling; or
- Serious, whether expected or not, i.e., that requires being admitted to the hospital, lengthened hospital stay, causes a birth defect, disability, is life-threatening or results in death;
- Reactions to recently marketed health products (on the market for less than five years), regardless of their nature or severity.
|
Resource |
Description |
Summary Basis of Decision for Emend ™
|
The Summary Basis of Decision explains why the product was approved for sale in Canada. The document includes regulatory, safety, effectiveness and quality (in terms of chemistry and manufacturing) considerations.
|
Search Clinical Information |
After Health Canada completes the regulatory review process for a product, the clinical information included in a submission is made publicly available for non-commercial purposes. |
Resource |
Description |
Summary Basis of Decision for Emend ™
|
The Summary Basis of Decision explains why the product was approved for sale in Canada. The document includes regulatory, safety, effectiveness and quality (in terms of chemistry and manufacturing) considerations.
|
Search Clinical Information |
After Health Canada completes the regulatory review process for a product, the clinical information included in a submission is made publicly available for non-commercial purposes. |
Resource |
Description |
Summary Basis of Decision for Emend ™
|
The Summary Basis of Decision explains why the product was approved for sale in Canada. The document includes regulatory, safety, effectiveness and quality (in terms of chemistry and manufacturing) considerations.
|
Search Clinical Information |
After Health Canada completes the regulatory review process for a product, the clinical information included in a submission is made publicly available for non-commercial purposes. |
Report a side effect |
Side effects are troublesome symptoms or feelings that you may not expect that show up when you are taking a medicine.
All suspected side effects should be reported, especially those that are:
- Unexpected, regardless of their severity, i.e., not consistent with product information or labelling; or
- Serious, whether expected or not, i.e., that requires being admitted to the hospital, lengthened hospital stay, causes a birth defect, disability, is life-threatening or results in death;
- Reactions to recently marketed health products (on the market for less than five years), regardless of their nature or severity.
|
Report a serious adverse drug reaction (for hospitals) |
Section C.01.020.1 of the Food and Drug Regulations and section 62 of the Medical Devices Regulations, require hospitals to report to Health Canada all serious adverse drug reactions (ADRs) and medical device incidents (MDIs) within 30 days of being documented within the hospital.
This regulatory requirement only applies to hospitals.
|